Regulatory Affairs Director for Rare Disease Therapies
14 hours ago
Company Overview:
CT19 is a European biotech organisation dedicated to developing novel therapeutics for rare diseases. With a strong portfolio ranging from preclinical to approved products, the company is expanding its pipeline with multiple new indications.
About the Role:
This exciting opportunity is for a Senior Director to lead Regulatory Affairs as Therapeutic Area Head. Reporting directly to the Global Head of Regulatory, you will play a pivotal role in ensuring regulatory approval across a diverse pipeline of assets. Your strategic decisions will drive the direction of the portfolio, making this role highly visible within the organisation.
Responsibilities:
- Lead a small team of Regulatory professionals, providing direction and motivation while giving them a voice at the table.
- Ensure regulatory approval for a diverse pipeline of assets through strategic decision-making.
- Collaborate closely with senior stakeholders, including Commercial & General Managers, to drive commercial strategy.
- Oversight of multiple products at different stages of their development lifecycle.
Requirements:
- Experience in marketing applications to FDA and EMA required.
- Rare disease and orphan drug experience essential.
- Haematology, rheumatology, or dermatology experience beneficial.
- People management experience with direct report oversight required.
- Commercial strategy experience and product portfolio oversight ideal.
Estimated Salary: £120,000 - £150,000 per annum, depending on experience. This salary reflects the role's responsibilities, location, and industry standards.
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